Manager Medical Study Operations

Manager, Medical Study Operations

As a Manager, Medical Study Operations you are responsible for all operational aspects of Global Medical Affairs Oncology, including Investigator-Initiated Studies (IIS), Research Collaborations (RC), and Data Transparency requests across multiple products and new molecules. Ensuring compliance with applicable standards and regulations.

This position will require you to be on-site 4 days/week at our Sleepy Hollow, NY offices. If eligible, we can offer relocation benefits. We cannot offer a remote work option.

A typical day may include the following:

• Manage multiple projects/programs, including IIS, Research Collaborations, and Data Transparency, with moderate direction.
• Ensure proposals align with Areas of Interest, are complete, and reviewed by the appropriate governing bodies. Obtain all necessary approvals, including those from the Medical Affairs Review Committee (MARC), Collaborator/Partners, and Senior Management, for both original proposals and amendments.
• Facilitate meetings and committees, including setting agendas, driving goals, documenting outcomes, and ensuring follow-up on action items. Coordinate scientific meetings with external investigators and the Field Medical Team.
• Track and report study progress, data delivery, program impact, and other relevant metrics.
• Ensure collection, tracking, and archiving of all relevant documents, including regulatory submissions, IRB/EC approvals, and Health Authority communications.
• Ensure patent reviews, due diligence (e.g., OIG exclusion list, FDA debarment), and background checks for compliance.
• Collaborate with Site Budget & Contracting, Legal, Procurement, and Sponsor Institution to ensure agreement meets study requirements.
• Oversee study budgets, including Fair Market Value (FMV) analysis, approvals, and purchase orders (POs). Manage POs, achievements, invoicing, accruals, projections, and budget planning. Handle budget changes, reforecasts, and reconciliations while ensuring effective communication with partners.
• Plan and coordinate drug campaigns with Drug Supply Functions, ensuring compliance with packaging, labeling, and country-specific requirements.
• Manage drug shipments, resupply, expiry, quarantines, and destruction of unusable products.
• Ensures timely receipt and reconciliation of Serious Adverse Events (SAEs) and Investigator Alert Letters (IAL) in compliance with regulatory requirements.
• Coordinate internal review of publications, consolidate feedback, and document actions taken.
• Ensure data capture in study management tools and document repositories for audit readiness.
• Adhere to all relevant processes, training, and SOPs to ensure consistency, efficiency, and compliance.

To be considered a minimum of BA/BS degree in a related field with 7+ years of industry or relevant professional experience in clinical research. Experience in oncology and/or antibody research is a plus. Experience with Investigated Initiated Studies is preferred.

Salary Range (annually): $114,800.00 - $187,400.00